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Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes

Primary Purpose

Type 1 Diabetes

Status

Unknown status

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Gamma Aminobutyric Acid (GABA)

Placebo

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

5 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Be between the ages of 5 and 21 years*
Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria
Must have stimulated C-peptide levels ≥0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month of randomization
Presence of at least one diabetes-related autoantibody
Must be willing to comply with intensive diabetes management and monitor glucose with glucometer.
If participant is female with reproductive potential, she must be willing to avoid pregnancy during the whole study period and have a negative pregnancy test
Parents and participants must sign the informed consent

Exclusion Criteria:

Be currently pregnant or lactating or anticipate getting pregnant during the study period.
Type 2 diabetes and other specific types of diabetes.
Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism.
Have a history of malignancies
Be currently using non-insulin pharmaceuticals to affect glycemic control
Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk.
Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles
Inability or unwillingness to comply with the provisions of this protocol
Have an active infection or positive PPD test result.
Have serologic evidence of current or past HIV, Hep B, or Hep C infection.
Be with acute complications of diabetes (diabetic ketoacidosis, nonketotic hypersmolar coma, diabetic lactic acidosis)
Have a history of chronic renal failure, serum creatinine higher than 177umol/L
Have a history of impaired liver function, ALT or AST level elevated more than (or equal to) 2.5 times of upper limmit normal.

Sites / Locations

Department of Endocrinology and Metabolism，Huashan hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Gamma Aminobutyric Acid (GABA)

Gamma Aminobutyric Acid GABA)

placebo

Arm Description

GABA will be given 50mg/kg/Day, thrice daily for 52 weeks

GABA will be given 100mg/kg/Day, thrice daily for 52 weeks.

placebo will be given thrice daily for 52 weeks

Outcomes

Primary Outcome Measures

C-peptide value

The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up.

Secondary Outcome Measures

HbA1C level

The study will examine the HbA1C level every 3 months from baseline and up to 52 weeks.

Full Information

NCT ID

NCT01781884

First Posted

January 12, 2013

Last Updated

January 31, 2013

Sponsor

Huashan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01781884

Brief Title

Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes

Official Title

Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

January 2013 (undefined)

Primary Completion Date

December 2014 (Anticipated)

Study Completion Date

December 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Huashan Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study is a multicenter, randomized, double-masked, placebo-controlled clinical study. All groups will receive standard intensive diabetes treatment with insulin and life style management. 60 subjects will be randomly assigned in a 1:1:1 ratio to receive placebo or different dosage of GABA. GABA is an amino acid produced from glutamate by glutamic acid decarboxylase. It was approved for the treatment of hepatic coma, fibromyalgia, ataxia in China and is widely used as supplement for the treatment of epilepsy, insomnia, stress and tobacco dependence. It has been recently shown that GABA can prevent and reverse the development of diabetes in type 1 mice models. Participants will receive placebo or GABA for 52 weeks. The study will consist of 4 weeks screening period, 2 weeks run-in period, 52 weeks treatment period and 4 weeks follow-up period. Enrollment is expected to occur over 2 years. To assess the efficacy and safety of GABA for the treatment of juvenile type 1 diabetes in new onset subjects.

Detailed Description

Primary Outcome: The primary statistical hypothesis to be assessed in this study is whether the mean C-peptide value for study subjects receiving GABA differs significantly from the mean value for placebo subjects assessed at follow-up. Secondary Outcome: The study will examine the HbA1C and the daily dosage of insulin (units/kg). Exploratory Endpoint: The study will assess the effects of treatment on inflammatory markers and immunological outcomes. Major Inclusion Criteria: Type 1 diabetes within past 6 months Age 5-21 years* At least one diabetes associated autoantibody

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gamma Aminobutyric Acid (GABA)

Arm Type

Active Comparator

Arm Description

GABA will be given 50mg/kg/Day, thrice daily for 52 weeks

Arm Title

Gamma Aminobutyric Acid GABA)

Arm Type

Active Comparator

Arm Description

GABA will be given 100mg/kg/Day, thrice daily for 52 weeks.

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

placebo will be given thrice daily for 52 weeks

Intervention Type

Drug

Intervention Name(s)

Gamma Aminobutyric Acid (GABA)

Other Intervention Name(s)

Gamma Aminobutyric Acid

Intervention Description

two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

C-peptide value

Description

Time Frame

baseline and up to 52 weeks

Secondary Outcome Measure Information:

Title

HbA1C level

Description

The study will examine the HbA1C level every 3 months from baseline and up to 52 weeks.

Time Frame

baseline and up to 52 weeks

Other Pre-specified Outcome Measures:

Title

Daily dosage of insulin (units/kg).

Description

The study will assess the daily dosage of insulin (units/kg).

Time Frame

baseline and up to 52 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Be between the ages of 5 and 21 years* Be within 6-months of diagnosis of type 1 diabetes based on American Diabetes Association (ADA) criteria Must have stimulated C-peptide levels ≥0.2 pmol/ml measured during a mixed meal tolerance test (MMTT) conducted at least 21 days from diagnosis of diabetes and within one month of randomization Presence of at least one diabetes-related autoantibody Must be willing to comply with intensive diabetes management and monitor glucose with glucometer. If participant is female with reproductive potential, she must be willing to avoid pregnancy during the whole study period and have a negative pregnancy test Parents and participants must sign the informed consent Exclusion Criteria: Be currently pregnant or lactating or anticipate getting pregnant during the study period. Type 2 diabetes and other specific types of diabetes. Require use of systemic immunosuppressant, steroids or other medications that can affect glucose metabolism. Have a history of malignancies Be currently using non-insulin pharmaceuticals to affect glycemic control Have any acute or chronic complicating medical issues or abnormal clinical laboratory results that interfere with study conduct or cause increased risk. Have a history of epilepsy, significant head trauma or cerebrovascular accident or clinical features of continuous motor unit activity in proximal muscles Inability or unwillingness to comply with the provisions of this protocol Have an active infection or positive PPD test result. Have serologic evidence of current or past HIV, Hep B, or Hep C infection. Be with acute complications of diabetes (diabetic ketoacidosis, nonketotic hypersmolar coma, diabetic lactic acidosis) Have a history of chronic renal failure, serum creatinine higher than 177umol/L Have a history of impaired liver function, ALT or AST level elevated more than (or equal to) 2.5 times of upper limmit normal.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yiming Li, Doctor

Organizational Affiliation

Huashan Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Qinghua Wang, Doctor

Organizational Affiliation

St Michale's Hospital, University of Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Endocrinology and Metabolism，Huashan hospital

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200040

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zhaoyun Zhang

Phone

86-21-52888286

First Name & Middle Initial & Last Name & Degree

Yi Wang

Phone

86-21-52887022

First Name & Middle Initial & Last Name & Degree

Yiming Li

First Name & Middle Initial & Last Name & Degree

Qinghua Wang, Doctor

12. IPD Sharing Statement

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Effects Of Gamma Aminobutyric Acid On The Progression Of New Onset Juvenile Type 1 Diabetes

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